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Evaluation of the Efficacy and Safety of Lebrikizumab (LY3650150) in Moderate to Severe Atopic Dermatitis (ADvocate2)

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ClinicalTrials.gov Identifier: NCT04178967
Recruitment Status : Active, not recruiting
First Posted : November 26, 2019
Last Update Posted : August 13, 2021
Sponsor:
Collaborator:
Dermira, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: Lebrikizumab Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, parallel group, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.
Actual Study Start Date : October 29, 2019
Actual Primary Completion Date : July 12, 2021
Estimated Study Completion Date : June 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Placebo Comparator: Placebo

Induction Period (Baseline-Week 16):

Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Maintenance Period (Week 16-Week 52):

Treatment from Week 16 to Week 52 is based on re-randomization of responders in the Induction Period. Participants re-randomized to Placebo arm receive two Placebo injections Q2W.

Other: Placebo
Subcutaneous Injection

Experimental: Lebrikizumab Q2W

Induction Period (Baseline-Week 16):

Two subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 visits followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14.

Maintenance Period (Week 16-Week 52):

Treatment from Week 16 to Week 52 is based on re-randomization of responders in the Induction Period. Participants re-randomized to Lebrikizumab Q2W arm receive two lebrikizumab injections Q2W.

Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • LY3650150
  • DRM06

Experimental: Lebrikizumab Q4W

Maintenance Period (Week 16-Week 52):

Treatment from Week 16 to Week 52 is based on re-randomization of responders in the Induction Period. Participants re-randomized to Lebrikizumab Q4W arm receive one lebrikizumab injection Q4W, with one placebo injection 2 weeks after each lebikizumab injection.

Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • LY3650150
  • DRM06

Other: Placebo
Subcutaneous Injection

Experimental: Escape Arm (Lebrikizumab Q2W)

Maintenance Period (Week 16-Week 52):

Participants who require rescue treatment for atopic dermatitis during the Induction Period, or are non-responders at Week 16, will be eligible for treatment in an Escape Arm where participants will receive open-label lebrikizumab Q2W from Week 16 through Week 52. In addition, participants who do not maintain an acceptable response during the Maintenance Period (have an EASI score <50% of baseline), will be eligible for the Escape Arm.

Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • LY3650150
  • DRM06




Primary Outcome Measures :
  1. Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  2. Percentage of participants achieving EASI-75 (≥75% reduction in EASI score) from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
  2. Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  3. Percentage of participants achieving EASI-90 (≥90% reduction in EASI score) from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  4. Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
  5. Percentage of participants with a Pruritus NRS score of ≥4-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  6. Percentage of participants with a Pruritus NRS score of ≥5-points at Baseline who achieve a ≥4-point reduction in Pruritus NRS score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  7. Percentage change in EASI score from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
  8. Change from Baseline to Week 16 in percent BSA [ Time Frame: Baseline, Week 16 ]
  9. Percentage of participants achieving EASI-90 from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  10. Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16 [ Time Frame: Baseline, Week 16 ]
  11. Percentage of participants achieving ≥4-point improvement in DLQI from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  12. Percentage of participants with a DLQI total score of ≥4-point achieving ≥4-point improvement in DLQI from baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  13. Percentage change in Sleep-loss score from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
  14. Change from Baseline in Sleep-loss score at Week 16 [ Time Frame: Baseline, Week 16 ]
  15. Percentage of participants with a Sleep-loss score ≥2 points at Baseline who achieve a ≥2 points reduction from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  16. Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1 [ Time Frame: Baseline to Week 1 ]
  17. Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
  18. Percentage of participants with a Pruritus NRS score of ≥4 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  19. Percentage of participants with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1 [ Time Frame: Baseline to Week 1 ]
  20. Percentage of participants with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
  21. Percentage of participants with a Pruritus NRS score of ≥5 points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  22. Percentage Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
  23. Pharmacokinetics (PK): Average serum concentration of Lebrikizumab [ Time Frame: Baseline through Week 16 ]
  24. Percentage of participants from those re-randomized having achieved EASI-75 at Week 16 who continue to exhibit EASI-75 at Week 52 (EASI-75 calculated relative to baseline EASI score) [ Time Frame: Baseline to Week 52 ]
  25. Percentage of participants from those re-randomized having achieved IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 16 who continue to exhibit an IGA 0 or 1 and a ≥2-point improvement from Baseline at Week 52 [ Time Frame: Baseline to Week 52 ]
  26. Percentage of participants from those with a Pruritus NRS of ≥4-points at baseline re-randomized having achieved ≥4-point reduction from baseline at Week 16 who continue to exhibit ≥4-point reduction from baseline at Week 52 [ Time Frame: Baseline to Week 52 ]
  27. Percentage of participants from those with a Pruritus NRS of ≥5-points at baseline re-randomized having achieved ≥4-point reduction from baseline at Week 16 who continue to exhibit ≥4-point reduction from baseline at Week 52 [ Time Frame: Baseline to Week 52 ]
  28. Percentage change in SCORAD (having achieved EASI-75 at Week 16) from baseline at Week 52 [ Time Frame: Baseline, Week 52 ]
  29. Change from Baseline in European Quality of Life-5 Dimensions (EQ5D) at Week 16 [ Time Frame: Baseline, Week 16 ]
  30. Change from Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 [ Time Frame: Baseline, Week 16 ]
  31. Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 [ Time Frame: Baseline, Week 16 ]
  32. Change from Baseline in PROMIS Depression at Week 16 [ Time Frame: Baseline, Week 16 ]
  33. Change from Baseline in Asthma Control Questionnaire (ACQ-5) score at Week 16 in participants who have self-reported comorbid asthma [ Time Frame: Baseline, Week 16 ]
  34. Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 [ Time Frame: Baseline, Week 16 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female adults and adolescents (≥12 years and ≥40 kg)
  • Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit
  • Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit
  • Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
  • ≥10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit
  • History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable

Exclusion Criteria:

  • Prior treatment with dupilumab or tralokinumab
  • Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
  • Treatment with any of the following agents within 4 weeks prior to the baseline visit:

    • Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
    • Phototherapy and photochemotherapy (PUVA) for AD
  • Treatment with the following prior to the baseline visit:

    • An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
    • Cell-depleting biologics, including to rituximab, within 6 months of baseline
    • Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer
  • Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study
  • Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma
  • Evidence of active acute or chronic hepatitis
  • History of human immunodeficiency virus (HIV) infection or positive HIV serology
  • History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178967


Locations
Show Show 89 study locations
Sponsors and Collaborators
Eli Lilly and Company
Dermira, Inc.
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04178967    
Other Study ID Numbers: 17802
2019-002933-12 ( EudraCT Number )
J2T-DM-KGAC ( Other Identifier: Eli Lilly and Company )
DRM06-AD05 ( Other Identifier: Dermira, Inc )
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases